Epigenomics' FDA Application for Cancer Test to Get FDA Priority Review | GenomeWeb

NEW YORK (GenomeWeb News) – Epigenomics today said that the US Food and Drug Administration has accepted its premarket approval application for its colorectal cancer test and has granted the application priority review status.

The Berlin, Germany-based firm filed the PMA for its Epi proColon test in December, after successfully completing a head-to-head comparative study with fecal immunochemical test screening. The submission was the fourth and final module of the PMA.

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